The examination of blood samples or other samples of body fluids, such as interstitial fluid, for example, enables, in clinical diagnostics, early and reliable identification of pathological states and targeted and astute monitoring of body states. Medical diagnostics generally presupposes that a sample of blood or interstitial fluid is obtained from the patient to be examined. In order to obtain the sample, the skin of the person to be examined can be perforated, for example at the finger pad or the ear lobe, with the aid of a sterile, pointed or sharp lancet in order thus to obtain a few microliters of blood or less for analysis. In particular, this method is suitable for an analysis of the sample which is carried out directly after the sample has been obtained. Primarily in the field of so-called “home monitoring”, that is to say where medical laypersons themselves carry out simple analyses of blood or interstitial fluid, in particular for diabetics obtaining blood samples on a regular basis, several times a day, to monitor the blood glucose concentration, lancets and associated devices (so-called puncturing aids) are offered. These are described for example in WO-A 98/48695, U.S. Pat. Nos. 4,442,836, 5,554,166 or WO 2006/013045 A1.
Self-monitoring of blood sugar levels is a method of diabetes control that is nowadays applied worldwide. Blood sugar devices in the prior art generally have an analysis device into which a test element (for example a test strip) is introduced. The sample to be analyzed is applied to a test field of a test element and reacts in the test field with one or more reagents, if appropriate, before it is analyzed. Optical, in particular photometric, and electrochemical evaluation of test elements are the most common methods for rapidly determining the concentration of analytes in samples. Analysis systems comprising test elements for sample analysis are generally used in the field of analysis, environmental analysis, and primarily in the field of medical diagnostics. Test elements which are evaluated photometrically or electrochemically are of great significance particularly in the field of blood glucose diagnostics from capillary blood.
The prior art discloses various forms of test elements and test devices for the evaluation thereof. By way of example, strip-type test elements can be used, such as are described for example in the documents CA 2311496 A1, U.S. Pat. Nos. 5,846,838 A, 6,036,919 A or WO 97/02487. Further multilayered test elements known in the prior art are analysis tapes comprising a multiplicity of test fields which are provided in a cassette in a manner wound up for use in an analysis device. Such cassettes and analysis tapes are described for example in the documents DE 10 332 488 A1, DE 10 343 896 A1, EP 1 424 040 A1, WO 2004/056269 A1 and US 2006/0002816 A1. Besides analysis tapes comprising test fields, analysis tapes in which lancets are arranged on a carrier tape have also become known in the meantime, wherein the individual lancets, by means of tape transport, can be progressively used and also disposed of again. One example of a system of this type is shown in WO-A 2005/107596. Hereinafter, therefore, an “analysis tape” is understood to mean a tape with any desired type of diagnostic aids, wherein the diagnostic aids can comprise any desired type of diagnostic aids, for example diagnostic test fields with a detection chemical and/or lancets.
Various methods are known for producing the analysis tapes. These methods have to satisfy numerous stringent requirements since, in the field of medical diagnostics, stringent requirements are made for example of freedom from contamination for the analysis tapes, and also stringent requirements are made of the quality and the reproducibility of the diagnostic aids applied on the analysis tapes. At the same time, however, the analysis tapes have to be produced cost-effectively since medical diagnostics is under constantly increasing cost pressure.
EP 1 593 434 A2 discloses a method and a device for producing an analysis tape for fluid samples. In this case, a rollable transport tape is provided with a multiplicity of test fields situated at a distance from one another in the direction of the tape for analyzing the fluid samples, in which case a multilayered test label tape is prefabricated at least from a detection film and an adhesive tape and the test fields are subsequently transferred as self-adhesive test labels from the test label tape to the transport tape. For this purpose, it is proposed that a multitrack label tape is subdivided into multiple test labels in sections by stamping and removing a stamping grid, said multiple test labels subsequently being transferred to the transport tape in a labeling method.
This known method allows cost-effective and precise production of high-quality analysis tapes. It has been found here during use in practice, however, that the analysis method described in EP 1 593 434 A2 is restricted in terms of throughput, such that labeling tolerances which exceed the predetermined maximum tolerances may occur at tape speeds of the carrier tape of tens of m/min.
A further disadvantage of the known labeling methods, such as the method known from EP 1 593 434 A2, for example, is that large amount of rejects arise during labeling. Thus, by way of example, the stamping and removal of the stamping grid as described in EP 1 593 434 A2 are associated with considerable rejects, which, in view of the high quality of the test chemical used and the complex construction of the multitrack label tape used, considerably increases the production costs.
Therefore, it is an object of the present invention to provide a method for producing an analysis tape and also a corresponding device which avoid the disadvantages of known methods and devices. In particular, the method is intended to be suitable for production with a high throughput, good precision and low defect tolerance being achieved even at high throughputs.